Clinical Trials Logo

Clinical Trial Summary

Study J4B-MC-OKAA is a Phase 1/2, multi-center, open-label ascending dose, first-in-human study that will evaluate the safety and effect of intra-cisternal LY3884963 administration on progranulin protein (PGRN) levels in patients with frontotemporal dementia with progranulin mutations (FTD-GRN). Two escalating dose (low dose and medium dose) cohorts are planned, as well as one bridging cohort which will allocate patients to receive either low or medium dose. The duration of the study is 5 years. During the first year, patients will be evaluated for the effect of LY3884963 on safety, tolerability, immunogenicity, biomarkers, and efficacy. Patients will follow up for an additional 4 years to monitor safety and changes on selected biomarkers and clinical outcomes.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04408625
Study type Interventional
Source Prevail Therapeutics
Contact Prevail Therapeutics
Phone (917) 336-9310
Email prevail.patients@lilly.com
Status Recruiting
Phase Phase 1/Phase 2
Start date November 9, 2020
Completion date August 31, 2029

See also
  Status Clinical Trial Phase
Recruiting NCT05288842 - Tanycytes in Alzheimer's Disease and Frontotemporal Dementia
Recruiting NCT03272230 - Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System N/A
Active, not recruiting NCT03987295 - A Phase 2 Study to Evaluate Safety of Long-term AL001 Dosing in Frontotemporal Dementia (FTD) Patients (INFRONT-2) Phase 2
Withdrawn NCT05497817 - A Study to Evaluate Caregiver Connections Via Technology for Patients With Alzheimer's and Other Types of Dementia N/A
Recruiting NCT04918251 - EEG and TMS-based Biomarkers of ALS, MS and FTD
Completed NCT01890343 - Imaging Characteristics of Florbetapir 18F in Patients With Frontotemporal Dementia, Alzheimer's Disease and Normal Controls. Phase 2
Completed NCT01002300 - Oxytocin and Social Cognition in Frontotemporal Dementia N/A
Completed NCT00376051 - Serotonergic Function and Behavioural and Psychological Symptoms of Frontotemporal Dementia Phase 4
Terminated NCT00159198 - Amyotrophic Lateral Sclerosis and Frontotemporal Dementia Phase 1
Active, not recruiting NCT04516499 - Neurofilament Surveillance Project (NSP)
Recruiting NCT04747431 - A Study of PBFT02 in Patients With Frontotemporal Dementia and Progranulin Mutations (FTD-GRN) Phase 1/Phase 2
Completed NCT03636204 - A First in Human Study in Healthy Volunteers and in Participants With Frontotemporal Dementia With Granulin (GRN) Mutation Phase 1
Completed NCT01937013 - Impact of Emotional Mimicry and Oxytocin on Frontotemporal Dementia Phase 2
Active, not recruiting NCT05075187 - Epidemiological Study in FRONtoTemporal Dementia
Not yet recruiting NCT05004558 - Effects of Remote-based Resistance Training on Cardiometabolic Risk Factors, Cognitive Function, and Quality of Life in Adults Living With Alzheimer's Disease and/or Related Dementias N/A
Completed NCT02999282 - Rehabilitative Trial for the Rescue of Neurophysiological Parameters in Progranulin Deficient Subjects N/A
Completed NCT00594737 - Open Label Pilot Study of the Effects of Memantine on FDG-PET in Frontotemporal Dementia Phase 3
Recruiting NCT03225144 - Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Active, not recruiting NCT04993755 - A Phase 2a Study of TPN-101 in Patients With C9ORF72 ALS/FTD Phase 2
Recruiting NCT04114994 - Longitudinal Cognitive Assessment by BoCA